FDA seeks input from stakeholders, public on regulatory approval pathway for follow-on biologics

By Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration is moving forward in the creation of a regulatory approval pathway for follow-on biologics and is requesting input from stakeholders and the public, the agency said Monday.

The FDA plans to use the input it gets to create a user fee program for regulatory approval applications.

In addition to accepting written comments, the agency will consult with scientific and academic experts, healthcare professionals, patient and consumer advocacy groups and companies.

A Federal Register notice displayed Monday described the principles the agency proposes to develop the program, a proposed structure for it and proposed performance goals. The notice is available here.